## Facts

- Myriad Genetics discovered the location and nucleotide sequence of the BRCA1 and BRCA2 genes, mutations of which are associated with elevated breast and ovarian cancer risk.
- Myriad obtained patents claiming (1) “isolated” DNA segments corresponding to BRCA1/BRCA2 and (2) complementary DNA (cDNA) corresponding to those genes, along with other claims not central to the Supreme Court’s review.
- Medical organizations, researchers, genetic counselors, and patients filed a declaratory-judgment action challenging the patent eligibility of Myriad’s gene-related claims under 35 U.S.C. § 101.
- The district court held the challenged composition claims and certain method claims invalid as covering products of nature and routine scientific activity.
- The Federal Circuit held isolated DNA and cDNA patent-eligible, reasoning isolation created chemically distinct molecules.
- The Supreme Court granted certiorari to decide whether the claimed human gene-related subject matter is patent-eligible.

## Issues

1. Whether claims to “isolated” naturally occurring DNA segments fall within patent-eligible subject matter under 35 U.S.C. § 101 or are unpatentable products of nature.
2. Whether claims to cDNA corresponding to naturally occurring genes are patent-eligible under § 101.

## Decision

- The Court held that a naturally occurring DNA segment is a product of nature and not patent-eligible merely because it has been isolated.
- The Court held that cDNA is generally patent-eligible because it is not naturally occurring, subject to a qualification for very short sequences that may be indistinguishable from natural DNA.
- The Court affirmed in part and reversed in part the Federal Circuit, invalidating claims to isolated genomic DNA while sustaining cDNA claims as a general matter.
- The Court stated that method claims, drug-screening claims, and claims involving altered nucleotide order were not before it and were not decided.

## Legal Principles

- Section 101 contains implicit exclusions: laws of nature, natural phenomena, and abstract ideas are not patentable.
- Discovering the location and sequence of a gene, without creating or altering the genetic information, is discovery of a natural phenomenon rather than an invention.
- A claim directed to genetic information that exists in nature remains ineligible even if obtaining the claimed material requires technical steps such as isolation.
- Synthetic genetic constructs that do not occur in nature, such as typical exon-only cDNA created in the laboratory, can qualify as patent-eligible compositions of matter, subject to other patentability requirements.

## Conclusion

The Court drew a line between discovery and invention under § 101: isolating naturally occurring genomic DNA does not make it patentable, but creating nonnaturally occurring cDNA generally does, leaving other gene-related method and application claims for separate analysis.


Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)